Healthy AdultsPhase 1NCT07731100
A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults
A Phase 1 study testing Prifetrastat in people with Healthy Adults, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Prifetrastat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2026to 2 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females of nonchildbearing potential and males ≥18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- Body mass Index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- Any prior use of epigenetic modifying agents.
- Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 days after the last dose of prifetrastat.
- Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO EVALUATE THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF PRIFETRASTAT
The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.
This study is seeking participants who are:
Read more
- Healthy males and females of nonchildbearing potential ≥18 years of age at screening
The participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized.
The results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and have one follow up contact.
- Conditions
- Healthy Adults
- Being tested
- Prifetrastat
- Keywords
- Prifetrastat, Food Effect, PF-07248144
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrifetrastatDrug
Also called PF-07248144
Participants will receive Prifetrastat as a single dose, oral tablet on Day 1 of Period 1 and Day 1 of Period 2 with a washout period between two doses
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | Period 1 (Treatment A) : PF-07248144 single dose following an overnight fast Period 2 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Treatments A and B will be separated with a washout of at least 14 days Receives: Drug: Prifetrastat |
| Sequence BA | Experimental | Period 1 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Period 2 (Treatment A): PF-07248144 single dose following an overnight fast Treatments B and A will be separated with a washout of at least 14 days Receives: Drug: Prifetrastat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Maximum observed plasma concentration (Cmax) for Prifetrastat
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Secondary outcomes (5)
Number of participants with treatment-emergent adverse events
Measured: Up to 28 to 35 days post last study intervention dose
Number of participants with laboratory test abnormalities
Measured: Up to 28 to 35 days post last study intervention dose
Number of participants with vital signs values meeting categorical summarization criteria
Measured: Up to 28 to 35 days post last study intervention dose
Number of participants with clinically significant physical examination abnormalities
Measured: Up to 28 to 35 days post last study intervention dose
Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements
Measured: Up to 28 to 35 days post last study intervention dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start24 Jul 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731100
- Sponsor's protocol ID
- C4551008
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO EVALUATE THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF PRIFETRASTAT
- ClinicalTrials.gov ID
- NCT07731100
- Acronym / sponsor ID
- C4551008
- Conditions
- Healthy Adults
- Keywords
- Prifetrastat, Food Effect, PF-07248144
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.
This study is seeking participants who are:
- Healthy males and females of nonchildbearing potential ≥18 years of age at screening
The participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized.
The results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and have one follow up contact.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Experimental | Drug: PrifetrastatPeriod 1 (Treatment A) : PF-07248144 single dose following an overnight fast Period 2 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Treatments A and B will be separated with a washout of at least 14 days |
| Sequence BA | Experimental | Drug: PrifetrastatPeriod 1 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Period 2 (Treatment A): PF-07248144 single dose following an overnight fast Treatments B and A will be separated with a washout of at least 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females of nonchildbearing potential and males ≥18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- Body mass Index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (4 listed)
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- Any prior use of epigenetic modifying agents.
- Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 days after the last dose of prifetrastat.
- Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrifetrastatAlso: PF-07248144Participants will receive Prifetrastat as a single dose, oral tablet on Day 1 of Period 1 and Day 1 of Period 2 with a washout period between two doses | Drug | Sequence AB, Sequence BA |
Primary outcome
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Maximum observed plasma concentration (Cmax) for Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
5 secondary outcomes
Number of participants with treatment-emergent adverse events
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with laboratory test abnormalities
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with vital signs values meeting categorical summarization criteria
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements
Time frame: Up to 28 to 35 days post last study intervention dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prifetrastat in people with Healthy Adults, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.